The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.

Start Date14 Nov 2014

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

NCT02128269 / TerminatedPhase 2

An Open-Label Proof of Concept Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.

Start Date01 Apr 2014

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

NCT01883544 / CompletedPhase 1

A Phase 1, Randomized, Blinded, Placebo-Controlled, Multiple IV Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and female subjects.

Start Date01 Jun 2013

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

100 Clinical Results associated with Olendalizumab

100 Translational Medicine associated with Olendalizumab

100 Patents (Medical) associated with Olendalizumab

Literatures (Medical) associated with Olendalizumab

01 Sep 2023·Bone marrow transplantation

A prospective phase 2 clinical trial of a C5a complement inhibitor for acute GVHD with lower GI tract involvement.

Article

Author: Holtan, Shernan G ; Dai, Yang ; Yao, Bert ; Overman, Bethany ; Anderson, Kevin ; Cahn, Jean Yves ; Socié, Gerard ; Mujeebuddin, Arshad ; Alousi, Amin ; Shpall, Elizabeth ; Champlin, Richard ; Ali, Haris ; Gill, Saar ; Ratanatharathorn, Voravit ; Mehta, Rohtesh S

Involvement of lower gastrointestinal tract (LGI) occurs in 60% of patients with graft-versus-host-disease (GVHD). Complement components C3 and C5 are involved in GVHD pathogenesis. In this phase 2a study, we evaluated the safety and efficacy of ALXN1007, a monoclonal antibody against C5a, in patients with newly diagnosed LGI acute GVHD receiving concomitant corticosteroid. Twenty-five patients were enrolled; one was excluded from the efficacy analysis based upon negative biopsy. Most patients (16/25, 64%) had acute leukemia; 52% (13/25) had an HLA-matched unrelated donor; and 68% (17/25) received myeloablative conditioning. Half the patients (12/24) had a high biomarker profile, Ann Arbor score 3; 42% (10/24) had high-risk GVHD per Minnesota classification. Day-28 overall response was 58% (13/24 complete response, 1/24 partial response), and 63% by Day-56 (all complete responses). Day-28 overall response was 50% (5/10) in Minnesota high-risk and 42% (5/12) in high-risk Ann Arbor patients, increasing to 58% (7/12) by Day-56. Non-relapse mortality at 6-months was 24% (95% CI 11-53). The most common treatment-related adverse event was infection (6/25, 24%). Neither baseline complement levels (except for C5), activity, nor inhibition of C5a with ALXN1007 correlated with GVHD severity or responses. Further studies are needed to evaluate the role of complement inhibition in GVHD treatment.

100 Deals associated with Olendalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11331	-	-	DB14834

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Graft Rejection	Phase 2	-	Alexion Pharmaceuticals, Inc.	-
Acute Graft Versus Host Disease	Phase 1	FR	Alexion Pharmaceuticals, Inc.	14 Nov 2014
Acute Graft Versus Host Disease	Phase 1	US	Alexion Pharmaceuticals, Inc.	14 Nov 2014
Antiphospholipid Syndrome	Phase 1	ES	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	IT	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	BR	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	GB	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	JP	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	US	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	FR	Immune Disease Institute, Inc.	-

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02245412 (GIGVHD, CTgov)	Phase 2	Acute Graft Versus Host Disease \| Graft versus host disease in gastrointestinal tract	25	ALXN1007 10 mg/kg once weekly (ALXN1007 10 mg/kg Once Weekly)	adqbjsicoz(dphofxcqip) = acqyfyhxtg nohbkibvqq (tduxxlotia, hiohuxavgx - rzdgbhwosz) View more	-	06 Oct 2017
NCT02245412 (GIGVHD, CTgov)	Phase 2		25	ALXN1007 20 mg/kg once weekly (ALXN1007 20 mg/kg Once Weekly)	adqbjsicoz(dphofxcqip) = oaczyxiioi nohbkibvqq (tduxxlotia, gkuslxzyya - vkxdmnfdpl) View more	-	06 Oct 2017
NCT02128269 (CTgov)	Phase 2	Antiphospholipid Syndrome	9	Study Drug- ALXN1007	myfrxvkltr(buctcesjbq) = hjstaqcbkl vjwbptwmcp (quhuojghro, slybmojnva - wsmmvjutxp) View more	-	13 Jul 2017

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